Generic Name: tocilizumab
Date of Approval: January 8, 2010
Company: Genentech USA, Inc.
Treatment for: Rheumatoid Arthritis
FDA Approves Actemra
The United States (US) Food and Drug Administration (FDA) approved Actemra (tocilizumab, RoActemra in the European Union) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Actemra, the result of a research & development collaboration with Chugai, is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).
Actemra Medication Guide
What is the most important information I should know about Actemra?
Actemra can cause serious side effects including:
Serious Infections
Actemra is a medicine that affects your immune system. Actemra can lower the ability of your immune system to fight infections. Some people have serious infections while taking Actemra, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
Your doctor should test you for TB before starting Actemra.
Your doctor should monitor you closely for signs and symptoms of TB during treatment with Actemra.
You should not start taking Actemra if you have any kind of infection unless your healthcare provider says it is okay.
Before starting Actemra, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as:
fever, sweating, or chills
muscle aches
cough
shortness of breath
blood in phlegm
weight loss
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
burning when you urinate or urinating more often than normal
feel very tired
are being treated for an infection
get a lot of infections or have infections that keep coming back
have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
have TB, or have been in close contact with someone with TB
live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidiomycosis, or blastomycosis). These infections may happen or become more severe if you use Actemra. Ask your healthcare provider, if you do not know if you have lived in an area where these infections are common.
have or have had hepatitis B.
After starting Actemra, call your healthcare provider right away if you have any symptoms of an infection. Actemra can make you more likely to get infections or make worse any infection that you have.
Tears (perforation) of the stomach or intestines.
Before taking Actemra, tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking Actemra get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away, and a change in your bowel habits.
Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start receiving Actemra and every 4 to 8 weeks during treatment to check for the following side effects of Actemra:
low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections.
low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
increase in certain liver function tests.
You should not receive Actemra if your neutrophil or platelet counts are too low or your liver function tests are too high.
Your healthcare provider may stop your Actemra treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving Actemra, and then every 6 months after that. Normal cholesterol levels are important to good heart health.
Cancer.
Actemra may decrease the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers. Tell your healthcare provider if you have ever had any type of cancer. See "What are the possible side effects with Actemra?" for more information about side effects.
What is Actemra?
Actemra is a prescription medicine called an Interleukin-6 (IL-6) receptor inhibitor. Actemra is used to treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a Tumor Necrosis Factor (TNF) antagonist has been used and did not work well.
It is not known if Actemra is safe and effective in children.
What should I tell my healthcare provider before receiving Actemra?
Actemra may not be right for you. Before starting Actemra, tell your healthcare provider if you:
have an infection.
have liver problems
have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
have or had a condition that affects your nervous system, such as multiple sclerosis
have recently received or are scheduled to receive a vaccine. People who take Actemra should not receive live vaccines. People taking Actemra can receive non-live vaccines
plan to have surgery or a medical procedure
have any other medical conditions
plan to become pregnant or are pregnant. It is not known if Actemra will harm your unborn baby.
Pregnancy Registry: Genentech has a registry for pregnant women who take Actemra. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking Actemra, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.
plan to breast-feed or are breast-feeding. You and your healthcare provider should decide if you will take Actemra or breast-feed. You should not do both.
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Actemra and other medicines may affect each other causing side effects.
Especially tell your healthcare provider if you take:
any other medicines to treat your RA. You should not take etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), or golimumab (Simponi), while you are taking Actemra. Taking Actemra with these medicines may increase your risk of infection.
medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I receive Actemra?
You will receive Actemra from a healthcare provider through a needle placed in a vein in your arm (IV or intravenous infusion). The infusion will take about 1 hour to give you the full dose of medicine.
You will receive a dose of Actemra about every 4 weeks.
If you miss a scheduled dose of Actemra, ask your healthcare provider when to schedule your next infusion.
While taking Actemra, you may continue to use other medicines that help treat your rheumatoid arthritis such as methotrexate, non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as instructed by your healthcare provider.
Keep all of your follow-up appointments and get your blood tests as ordered by your healthcare provider.
What are the possible side effects with Actemra?
Actemra can cause serious side effects, including:
Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while you use Actemra. This happens with other biologic medicines used to treat RA. Your doctor may do blood tests before you start treatment with Actemra and while you are using Actemra. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:
feel very tired
skin or eyes look yellow
little or no appetite
vomiting
clay-colored bowel movements
fevers
chills
stomach discomfort
muscle aches
dark urine
skin rash
Nervous system problems. Multiple Sclerosis has been diagnosed rarely in people who take Actemra. It is not known what effect Actemra may have on some nervous system disorders.
Allergic Reactions. Serious allergic reactions can happen with Actemra. These reactions may not happen with your first infusion, and may happen with future infusions of Actemra. Tell your healthcare provider right away if you have any of the following signs of a serious allergic reaction:
shortness of breath or trouble breathing
skin rash
swelling of the lips, tongue, or face
chest pain
feeling dizzy or faint
Common side effects of Actemra include:
upper respiratory tract infections (common cold, sinus infections)
headache
increased blood pressure (hypertension)
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Actemra. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.
General information about Actemra
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about Actemra.
If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Actemra that is written for health professionals.
For more information, go to www.actemra.com or call 1-800-ACTEMRA.
What are the ingredients in Actemra?
Active ingredient: tocilizumab
Inactive ingredients: sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate.
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